Regulatory Project Manager

Posted 08 August 2023
Job type Permanent
Contact NameRhiannon Ross

Job description

Regulatory Project Manager
Munich, Germany
This position covers project management of regulatory activities from early development, i.e. pre-clinical scientific advice to Project Management of dossier preparation for MAA or BLA/NDA filing.

Tasks & Responsibilities:
 Manage EU and FDA Marketing Authorisation Application procedures including:
    1. preparation of Module 1 documents
    2. assignment and management of team resources
    3. co-ordination of Mod 2 & 3
    4. tracking Modules 4 & 5
    5. preparation and track project plans
    6. interaction with Regulatory Agencies on behalf of clients before, during and after approval
    7. management the MAA procedure on behalf of clients
  • Provide regulatory advice to clients
  • Prepare and manage project plans
  • Request Scientific Advice meetings on behalf of clients including preparation of supportive documentation
  • Masters or PhD. in life sciences, medicine or veterinary medicine
  • At least 10 years Project Management and Regulatory Affairs experience, understanding of FDA and ICH regulations and guidelines
  • Competent with Project Management tools and software
  • Excellent communication skills, strategic thinker, solution orientated
  • Ability to work independently and manage multiple tasks simultaneously under time constraints. Flexible with excellent prioritisation skills